World-Class Biologics Manufacturing:
From Cell Bank to Bulk Drug Substance

Through sophisticated process development and high standard production technology.

cGMP Manufacturing

JHL Biotech has developed its own proprietary CHO-K1 cell line and uses this cell line for its own products and those of contract partners. JHL has established process development expertise that allows fine control of protein characteristics. Our robust development platform and scale-up strategies reliably translate from 3L models to GMP manufacturing at 2,000L, reducing the need for time consuming and costly iterations at full scale. JHL has a comprehensive, state-of-the art analytical portfolio applying orthogonal methods and is capable of developing liquid and lyophilized formulations. Both of JHL’s facilities utilize identical single-use manufacturing technologies provided by GE, Millipore, and other leading vendors. Our unified technical platform simplifies process development, manufacturing, and technical transfer. We have experience manufacturing batches for regulatory submission at, 50L, 200L, 500L, and 2,000L scales and have successfully designed and conducted clinical trials of biologics.

Our state-of-the-art facility is designed and built to meet highest FDA and EMA GMP requirements globally. JHL’s primary focus is on safety, compliance and flexibility. We strive to combine development with clinical and commercial demands for many products and to meet the needs of customers both today and for many years to come.

Our operations are fully integrated, with drug substance, drug products and quality control testing and release within the same location, to support a lean and efficient flow. We are using single use technology to minimize cleaning validation and product changes over time.

13,278 square meters facility and laboratories, including 2500 square meters of office space

A blend of 500L and 2000L disposable fermentation technology for mammalian cells drug substance production, for a total capacity of 9,000L

Upstream Production

Cell Line Seed Lab Cell Culture Purification Final Formulation

Media Preparation

Cell Line

Master Cell Bank (MCB)Master Cell Bank (MCB)

Seed Lab

Working Cell Bank (WCB)Working Cell Bank (WCB)

SENSOLUX Intelligent Shaker TraySENSOLUX Intelligent Shaker Tray
  • Selected clones stored in master cell bank (MCB)
  • Optimized clones transferred to working cell bank (WCB)
  • Vitals from WCB inoculated and expanded in shake flasks

Cell Culture

GE Xcellerex Bioreactor XDR-500Bioreactor for production

Millistak+® Pod Disposable Depth Filter SystemDepth filtration skid for harvesting
  • Media are prepared for seed and cell culture
  • Cells in shake flasks inoculated to 50L and 500L bioreactors for production
  • Cell culture fluid in the 500L bioreactor harvested via depth filtration to remove the cells and large particles
  • Harvested fluid transferred to downstream for purification

Downstream Production

Cell Line Seed Lab Cell Culture Purification Final Formulation

Buffer Preparation

Purification

GE ÄKTA ready Chromatography I to IIIChromatography I to III

Millipore Viresolve® Virus Filtration (VF) SkidVirus Filtration
  • Three chromatography steps to purify biologics
  • Common chromatography techniques include:
    • Protein A affinity chromatography as the first capture step
    • Ion-exchange columns to further remove remaining impurities
    • Purified products is filtered using virus filter to eliminate virus

Final Formulation

SciPure 200 Ultrafiltration/Diafiltration (UF/DF) SkidUltrafiltration/Diafiltration (UF/DF)

Bulk freeze bag in BioShell for storageBulk freeze bag in BioShell for storage
  • Virus-filtrate is concentrated and then buffer is exchanged using UF / DF into the desired formulated bulk active pharmaceutical ingredients (API)
  • Final bulk APIs are filled into the bulk freeze bags
  • Bulk freeze bags are stored in BioShells for protection during transportation
2000L GE Xcellerex Single-use Bioreactor
Millipore AKTA Ready Chromatography
Inside the KUBio Hall way
Millipore Harvest Skids
Millipore Harvest Skids

Impressed? We’d love to work with you!

JHL is open for partnerships and license agreements for its biosimilar assets worldwide. We can offer you access to our expertise in process development, manufacturing and regulatory management.